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Study of Anti-r-HuEpo Associated Pure Red Cell Aplasia (PRCA) Treatment

This study has been terminated.
(We observed >90 % efficacy in cyclophosphamide and Prednisolone group for treatment of anti-i-HuEpo associated PRCA)
Information provided by (Responsible Party):
Kearkiat Praditpornsilpa, Chulalongkorn University Identifier:
First received: February 1, 2011
Last updated: January 27, 2014
Last verified: January 2014
Recombinant human erythropoietin (r-HuEpo) has been used to treat renal anemia and improve morbidity and mortality in chronic kidney disease. Subcutaneous use of r-HuEpo causes immunogenicity and develops anti-r-HuEpo associated pure red cell aplasia (PRCA). The treatment of anti-r-HuEpo associated pure red cell aplasia is controversial. The investigators aim to evaluate the treatment for anti-r-HuEpo associated pure red cell aplasia in this study.

Condition Intervention Phase
Anti-r-HuEpo Associated PRCA Subjects
Drug: Cyclosporine combine with mycophenolate mofetil
Drug: Cyclophosphamide + pred
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Study of Anti-r-HuEpo Associated PRCA Treated by Cyclosporine and Mycophenolate Mofetil (MMF) Compared With Cyclophosphamide and Prednisolone

Resource links provided by NLM:

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • anti-r-HuEpo antibody [ Time Frame: Day 0 and month 6 ]
    The anti-r-HuEpo antibody titer at day 0 (before treatment) and month 6 (6th month after treatment) of each arm will be compared

Secondary Outcome Measures:
  • Absolute reticulocyte count [ Time Frame: Day 0 and month 6 ]
    The Absolute reticulocyte count at day 0 (before treatment) and month 6 (6th month after treatment) of each arm will be compared

Enrollment: 8
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CSA+MMF
Cyclosporine 100 mg BID combine with Mycophenolate mofetil 750 mg BID for 24 weeks
Drug: Cyclosporine combine with mycophenolate mofetil
Cyclosporine 100 mg BID and mycophenolate mofetil 750 mg BID for 24 weeks
Other Names:
  • Neoral
  • Cellcept
Active Comparator: Cyclophosphamide + pred
Cyclophosphamide 100 mg QD and prednisolone 1.0 mg/kg/day
Drug: Cyclophosphamide + pred
Cyclophosphamide 100 mg QD combine with prednisolon 1.0 mg/kg/day
Other Name: Endoxan

Detailed Description:
Recombinant human erythropoietin was the first biotherapeutic medicinal product derived from recombinant DNA technology for the treatment of anemia in patients with chronic kidney disease (CKD). Although r-HuEpo raises hemoglobin levels in CKD and improves morbidity associated with anemia in CKD patients, the adverse immunological effect of r-HuEpo administered subcutaneously can result in anti-r-HuEpo associated PRCA. We aim to evaluate the effectiveness of two treatment protocol, cyclosporine combined with mycophenolate mofetil and cyclophosphamide combined with prednisolone for treatment of anti-r-HuEpo associated PRCA.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age more than 18 years old
  • CKD patient with anti-r-huEpo associated PRCA

Exclusion Criteria:

  • Pregnancy or lactating women
  • Receiving immunosuppression
  • Active infection
  • Previous history of allergic reaction to cyclosporine, mycophenolate mofetil, cyclophosphamide, prednisolone
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Please refer to this study by its identifier: NCT01288131

Kearkiat Praditpornsilpa
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Principal Investigator: Kearkiat Praditpornsilpa, MD Chulalongkorn University
  More Information

Responsible Party: Kearkiat Praditpornsilpa, Associted Professor, Chulalongkorn University Identifier: NCT01288131     History of Changes
Other Study ID Numbers: 2011/01_Medicine
Study First Received: February 1, 2011
Last Updated: January 27, 2014

Keywords provided by Chulalongkorn University:
Anti-r-HuEpo antibody
Anti-r-HuEpo associated PRCA
Absolute reticulocyte count

Additional relevant MeSH terms:
Mycophenolate mofetil
Methylprednisolone Hemisuccinate
Mycophenolic Acid
Epoetin Alfa
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Calcineurin Inhibitors
Anti-Inflammatory Agents
Glucocorticoids processed this record on May 25, 2017